1. Field of the Invention
The present invention pertains to the field of diagnostic and therapeutic medical devices and procedures. More particularly, the present invention relates to the field of stabilization, imaging and procedure facilitating platforms for the female breast.
2. Description of the Related Art
Conventional breast stabilization devices and methods are a direct consequence from the technique of mammography. To obtain an acceptable mammographic image, the breast must be compressed and held immobile between two parallel plates. With the use of mammography to localize lesions for diagnostic procedures, the breast had to remain between the two compression plates for imaging and thereafter, to provide a platform from which to conduct the diagnostic procedure.
Compression of the breast is mandatory for a stereotactic biopsy. Indeed, compression is required to obtain the required mammographic views, as an adequate mammogram cannot be obtained unless the breast is in compression. The computer calculates the x, y and z coordinates targeting the lesion. The breast stays in compression during the entire localization and biopsying procedure.
Because of the required compression, the placement of the compression plates on the woman's breast determines the skin entry site for the procedure and, therefore, the scar location. Indeed, the position of the breast in the compression device dictates where the incision is to be made. The scar is most always on the side of the breast, whether superior, lateral, inferior or medial. The scar can range from about 5 mm in length to an unsightly 3 cm if a large coring device is used.
Examples of such devices and methods include that disclosed in U.S. Pat. No. 5,702,405 issued Dec. 30, 1997 to Heywang-Koebrunner. As described in this reference, the breast is compressed between two plates of a stereotactic attachment to a tomography device. Through holes are disposed in one of the two compression plates at an oblique angle within a plane that is substantially perpendicular to the plane of the plates, to allow a biopsy needle to access the breast through the side thereof Similarly, U.S. Pat. No. 4,563,768 to Read et al. discloses a mammographic device utilizing two parallel plates to compress the breast. One of the compression plates functions as an X-ray film holder. A matrix of perforations is disposed in one the compression plates, allowing access to the side of the breast by a biopsy needle or the like. U.S. Pat. No. 4,691,333 uses similar breast compression and side access technology. LaBash, in U.S. Pat. No. 5,499,989 discloses yet another breast compression scheme, in which the breast is stabilized by compression, whereupon a guide spool is aligned over an opening in one of the plates. The guide spool guides a tubular punch or a biopsy needle through the breast to the lesion site, puncturing the side of the compressed breast.
These and other similar devices share a number of disadvantages. From the patient's perspective, such breast compression devices and associated procedures are uncomfortable, awkward and painful. Indeed, such techniques often require the patient to assume an uncomfortable position to fit one of her breasts between the plates, which are then moved toward one another to compress the breast therebetween. This can be quite painful, as the degree of compression necessary to properly stabilize the breast in this manner is quite great.
To complicate matters, breast tissue often does not compress evenly, as the breast tissue may have localized regions of relatively greater or lesser densities that may slide against one another, a denser region being likely to push a relatively less dense area out of the way as the breast is compressed between the two parallel plates. In addition, the breast may have been slightly twisted as it was compressed. After an invasive procedure during which the breast was compressed as described above, the breast tissue expands, and the apparent profile of the path followed by the needle or other device (often coring its way through the tissue) may no longer be the straight path taken by the device when the breast was compressed. This results in an often curved or somewhat tortuous cavity in the breast. With a large coring device, this can cause permanent distortion and disfigurement.
Scars along the border of the areola are much less noticeable than scars of similar length made in the side surface of the breast. The areola is an ideal point of entry into the breast, as compared with the side top or bottom of the breast. However, conventional breast stabilizing devices are designed to allow access to the interior of the breast only from the side of the breast and not from the areola border.
Another technique for sampling or excising lesions in the breast involves sonographically targeting the lesion and manually carrying out a fine needle aspiration, core biopsy or vacuum assisted core biopsy. In such a procedure, the breast is not compressed and an ultrasound transducer is typically used to image the breast and the site of interest therein. In ultrasound guided biopsy, the physician must manually stabilize the breast, hold the ultrasound probe, and perform the biopsy accurately enough to obtain tissue from the lesion. Conventionally, this procedure is carried out by inserting the needle within the breast in an orientation that is as near parallel to the patient's chest wall as possible. The breast stabilization, the operation of the probe, as well as the actual needle biopsy must be carried out simultaneously, all the while maintaining the needle within the focal plane of the ultrasound probe. It is difficult to have an assistant help perform the procedure because if the ultrasound probe and/or needle are not exactly in line and are off by a fraction of a millimeter, then the needle cannot be visualized on the ultrasound monitor. Moreover, any movement of the patient (e.g., coughing, shifting) will also cause the biopsy device and ultrasound probe to misalign.
Imaging and invasive procedures on the uncompressed breast will alleviate the disadvantages associated with compressing the breast. Importantly, such procedures on the uncompressed breast would be less painful, would allow more choices for the entry site and would provide a means for excising tissue from the breast in its natural state.